MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST; IBC HFCWO VIBRATORY VEST

Model Number	8200
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's underlying pathology and medication may have contributed to the fractured ribs.The patient did not allege the device malfunctioned.The device was returned to ibc for investigation, and the device met all acceptance criteria.
Event or Problem Description
Respiratory therapist was informed that the user suffered several broken ribs.

• Brand Name: AFFLOVEST
• Common Device Name: IBC HFCWO VIBRATORY VEST
• Manufacturer (Section D): INTERNATIONAL BIOPHYSICS CORPORATION; 2101 e. st. elmo road; suite 275; austin TX 78744
• MDR Report Key: 8178717
• Report Number: 1645362-2018-00005
• Device Sequence Number: 1833553
• Product Code: BYI
• UDI-Device Identifier: 00814321020056
• UDI-Public: (01)00814321020056
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 8200
• Device Catalogue Number: 8200
• Device Lot Number: 090618-6642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Weight: 50